United States: The clinical hold of a phase 3 trial of Novavax’s COVID-19 and its standalone flu vaccines has been suspended by the FDA due to safety concerns that were grossly unrelated to the combination shot, as reported by Reuters.
The vaccine maker’s stock, poised to release its third-quarter financial data next week, increased by 17% to $10.39 on Monday. They cut their gains and were last up 2%.
Safety Concern
The Maryland-based biotech disclosed the clinical hold last month because a participant who received its COVID-influenza combination vaccine had shown signs of motor neuropathy, or damage to the nerve cells controlling muscles or movement.
The person received the vaccine shot in mid-stage trial in January last year.
Novavax said on Monday it had altered the participant’s symptoms to amyotrophic lateral sclerosis, a motor-neuron disease that impacts nerves in the brain and spinal cord, in further information submitted to the US health authority.
Evaluation carried out revealed that the operational symptoms had nothing to do with its shot, according to the company.
“The information provided to the FDA supported our assessment that the serious adverse event was not related to our vaccine,” said Chief Medical Officer Robert Walker.
He also pointed out that the company would return to late-stage trial activities as soon as possible.
The shares of Novavax dropped by 19% on Oct, 16 after the hold was announced.
Preparing for Late-Stage Trials
The COVID vaccine is currently the only product that the company has sold to the public after being in the market for over 35 years, and they are hoping on the combination shot and flu vaccine to be the product that will take the company to the next level to grow on.
Pfizer’s and Moderna’s shots use messenger RNA, a first-of-its-kind technology. In contrast, Novavax’s traditional protein-based COVID shot has remained out of the US vaccine market despite signing deals with the US government last year.
Securing Partnerships and Funding
Later in May, Novavax, through the licensing agreement of at least $1.2 billion with Sanofi, a French drug manufacturing firm for the COVID vaccine, secured funds so essential in its operation, as reported by Reuters.
Earlier, it had expressed uncertainty about its capacity to continue operations in the business.